To evaluate the safety and potential efficacy of deoxycholic acid injection compared to placebo for the reduction of submental fat (fat below the chin).
The trial included an initial cohort (3 participants in each arm) to evaluate safety followed by expansion to a second, larger cohort if adequate safety was determined in the initial cohort. Data from both cohorts was pooled for analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
85
Investigational Site
Carina Heights, Australia
Investigational Site
Gold Coast, Australia
Investigational Site
Toorak, Australia
Investigational Site
Oakville, Ontario, Canada
Number of Participants With Adverse Events
The investigator determined the relationship of each adverse event to the administration of study drug. Severity of adverse events was determined using the following scale: * Mild: The participant is aware of a sign or symptom, but it is easily tolerated * Moderate: Discomfort or interference with usual activity * Severe: Incapacitating, with inability to engage in usual activity. A serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that: * was fatal * was life-threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect * other significant medical hazard
Time frame: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations
Time frame: From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).
Change From Baseline in Submental Fat (SMF) Rating Scale Score
The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.
Time frame: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Change From Baseline in Subject Satisfaction With Appearance Rating Scale
The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.
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Investigational Site
Niagara Falls, Canada
Investigational Site
London, United Kingdom
Time frame: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)
Percentage of Participants With a Response in the Subject Global Improvement Rating
Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause. 0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved. Response is defined as any improvement, ie, a global improvement rating of 4, 5, or 6.
Time frame: 4 weeks after last treatment (up to 16 weeks after first dose)
Change From Baseline in Skin Laxity Rating
Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement.
Time frame: Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)
Change From Baseline in the Cervicomental Angle
The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.
Time frame: Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)